Device recall
Z-2467-2011: Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software…
FDA device recall · Class II · Hitachi Medical Systems America Inc
Key facts
| Recall number (Z-number) | Z-2467-2011 |
|---|---|
| Recall event | 58703 |
| Product | Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic… |
| Product code | IYN |
| Recalling firm | Hitachi Medical Systems America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2013 |
| 510(k) numbers | K093466, K102901 |
| FEI number | 1528028 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database